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Review of Chapter 2.3 of the National Statement: Qualifying or waiving conditions for consent submission

ID: 
27
This submission reflects the views of
Organisation Name: 
University of Technology Sydney
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Specific Questions
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
We would like to add the following in the section “Opt-out approach” 2.3.10 Before approving the use of an opt-out approach, an ethical review body must be satisfied that: a) involvement in the research carries no more than nil/negligible or low risk (see paragraphs 2.1.6 and 2.1.7, page 18) to participants
9. Can you provide examples where an opt-out approach may be useful?: 
UTS-relevant example where an opt-out approach might be useful is if a researcher is proposing the development of a database of student results (for example, if they want to follow for a number of years international students who first do a bridging course and then a particular degree with the aim of comparing their results with those of local students. Also, the approach might be useful for researchers proposing some observational research e.g. of audience reactions or interactions within a class (of adults) where the potential participants would be provided with information and be assumed to participate unless they specifically opted out.
General Comments
Comments: 

The UTS HREC is of the opinion that this is an excellent idea and the approach the NHMRC has set out is very clear and informative.

Page reviewed: 28 March, 2014